Kidney Failure, ChronicNCT07821788
Twice vs Thrice Weekly Hemodialysis: Clinical Outcomes and Quality of Life
An observational study of Kidney Failure, Chronic and Quality of Life, run by Assiut University.
Trial summary
This prospective cohort study aims to compare clinical outcomes and health-related quality of life between adults receiving established twice-weekly versus thrice-weekly maintenance hemodialysis at Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Quality of Life
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 10 Feb 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with end-stage kidney disease receiving maintenance in-center hemodialysis at Assiut University Hospitals.
Who may be able to join
- - Age 18 years or older
- Established end-stage kidney disease requiring maintenance hemodialysis
- Receiving in-center maintenance hemodialysis at Assiut University Hospitals
- On maintenance hemodialysis for at least one month before enrollment
- Established twice-weekly or thrice-weekly schedule prescribed by the treating team
- Clinically stable at recruitment
- Able to understand and respond to the questionnaire
- Written informed consent
Who cannot join
- - Acute kidney injury without established end-stage kidney disease
- Hemodialysis for less than one month
- Peritoneal dialysis or kidney transplantation during follow-up
- Acute severe illness requiring intensive care at recruitment
- Severe cognitive, psychiatric or neurological impairment preventing reliable questionnaire responses
- Active malignancy with expected survival too short to complete follow-up
Show all 9Show fewer
- Temporary dialysis solely for an acute indication
- Refusal to participate
- Permanent transfer to another dialysis center during follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcomes and Health-Related Quality of Life in Patients Receiving Twice- Versus Thrice-Weekly Maintenance Hemodialysis: A Prospective Comparative Study
This prospective cohort study aims to compare clinical outcomes and health-related quality of life between adults receiving established twice-weekly versus thrice-weekly maintenance hemodialysis at Assiut University Hospitals.
Read the detailed description
Thrice-weekly maintenance hemodialysis is the conventional schedule. Twice-weekly hemodialysis is used selectively in patients with residual kidney function. Local prospective comparative data in Egypt are limited.
This observational study will include adults with end-stage kidney disease receiving established twice-weekly or thrice-weekly in-center maintenance hemodialysis. Patients will be followed according to their prescribed schedule without research-driven changes. Health-related quality of life will be assessed using the Arabic KDQOL-36 at baseline, 3 months, and 6 months. Clinical outcomes including adequacy, residual kidney function, hospitalization, and mortality will be recorded.
- Conditions
- Kidney Failure, Chronic, Quality of Life
- Keywords
- Twice-weekly hemodialysis, Thrice-weekly hemodialysis, KDQOL-36, Residual kidney function, Quality of life
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Twice-weekly hemodialysis | Adults receiving established twice-weekly maintenance hemodialysis. | |
| Thrice-weekly hemodialysis | Adults receiving established thrice-weekly maintenance hemodialysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life score
Mean total score of the Arabic Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire. The KDQOL-36 score ranges from 0 to 100; higher scores indicate better health-related quality of life.
Measured: At baseline, 3 months, and 6 months
Secondary outcomes (5)
Dialysis adequacy
Mean single-pool Kt/V (for thrice-weekly) or weekly Kt/V incorporating residual kidney clearance (for twice-weekly).
Measured: Up to 6 months
Residual urine output
Mean daily urine volume (mL/day) in patients with residual kidney function.
Measured: Up to 6 months
Hospitalization rate
Proportion of patients requiring hospital admission during follow-up.
Measured: Up to 6 months
Interdialytic weight gain
Mean interdialytic weight gain (kg).
Measured: Up to 6 months
Mortality
Proportion of patients who die during the follow-up period.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin George Shawky Youssef, Assiut University
- Investigators
- marwa k abdo, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821788
- Sponsor's protocol ID
- HD-Frequency-QoL-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ackerman SD, Monk KR. The scales and tales of myelination: using zebrafish and mouse to study myelinating glia. Brain Res. 2016 Jun 15;1641(Pt A):79-91. doi: 10.1016/j.brainres.2015.10.011. Epub 2015 Oct 20.
PubMed 26498880Hastaoglu F, Mollaoglu M. The effects of activities of daily living education on the independence and life satisfaction of elders. Perspect Psychiatr Care. 2022 Oct;58(4):2978-2985. doi: 10.1111/ppc.13149. Epub 2022 Aug 27.
PubMed 36030386He XK, Su TT, Si JM, Sun LM. Metformin Is Associated With Slightly Reduced Risk of Colorectal Cancer and Moderate Survival Benefits in Diabetes Mellitus: A Meta-Analysis. Medicine (Baltimore). 2016 Feb;95(7):e2749. doi: 10.1097/MD.0000000000002749.
PubMed 26886616
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Health-Related Quality of Life in Patients Receiving Twice- Versus Thrice-Weekly Maintenance Hemodialysis: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07821788
- Acronym / sponsor ID
- HD-Frequency-QoL-Assiut-2026
- Conditions
- Kidney Failure, Chronic, Quality of Life
- Keywords
- Twice-weekly hemodialysis, Thrice-weekly hemodialysis, KDQOL-36, Residual kidney function, Quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study aims to compare clinical outcomes and health-related quality of life between adults receiving established twice-weekly versus thrice-weekly maintenance hemodialysis at Assiut University Hospitals.
Detailed description
Thrice-weekly maintenance hemodialysis is the conventional schedule. Twice-weekly hemodialysis is used selectively in patients with residual kidney function. Local prospective comparative data in Egypt are limited.
This observational study will include adults with end-stage kidney disease receiving established twice-weekly or thrice-weekly in-center maintenance hemodialysis. Patients will be followed according to their prescribed schedule without research-driven changes. Health-related quality of life will be assessed using the Arabic KDQOL-36 at baseline, 3 months, and 6 months. Clinical outcomes including adequacy, residual kidney function, hospitalization, and mortality will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twice-weekly hemodialysis | – | –Adults receiving established twice-weekly maintenance hemodialysis. |
| Thrice-weekly hemodialysis | – | –Adults receiving established thrice-weekly maintenance hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with end-stage kidney disease receiving maintenance in-center hemodialysis at Assiut University Hospitals.
Key inclusion criteria (8 listed)
- - Age 18 years or older
- Established end-stage kidney disease requiring maintenance hemodialysis
- Receiving in-center maintenance hemodialysis at Assiut University Hospitals
- On maintenance hemodialysis for at least one month before enrollment
- Established twice-weekly or thrice-weekly schedule prescribed by the treating team
Key exclusion criteria (9 listed)
- - Acute kidney injury without established end-stage kidney disease
- Hemodialysis for less than one month
- Peritoneal dialysis or kidney transplantation during follow-up
- Acute severe illness requiring intensive care at recruitment
- Severe cognitive, psychiatric or neurological impairment preventing reliable questionnaire responses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life score
Time frame: At baseline, 3 months, and 6 months
Mean total score of the Arabic Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire. The KDQOL-36 score ranges from 0 to 100; higher scores indicate better health-related quality of life.
5 secondary outcomes
Dialysis adequacy
Time frame: Up to 6 months
Residual urine output
Time frame: Up to 6 months
Hospitalization rate
Time frame: Up to 6 months
Interdialytic weight gain
Time frame: Up to 6 months
Mortality
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 26498880Ackerman SD, Monk KR. The scales and tales of myelination: using zebrafish and mouse to study myelinating glia. Brain Res. 2016 Jun 15;1641(Pt A):79-91. doi: 10.1016/j.brainres.2015.10.011. Epub 2015 Oct 20.
- Background: PubMed 36030386Hastaoglu F, Mollaoglu M. The effects of activities of daily living education on the independence and life satisfaction of elders. Perspect Psychiatr Care. 2022 Oct;58(4):2978-2985. doi: 10.1111/ppc.13149. Epub 2022 Aug 27.
- Background: PubMed 26886616He XK, Su TT, Si JM, Sun LM. Metformin Is Associated With Slightly Reduced Risk of Colorectal Cancer and Moderate Survival Benefits in Diabetes Mellitus: A Meta-Analysis. Medicine (Baltimore). 2016 Feb;95(7):e2749. doi: 10.1097/MD.0000000000002749.
Related trials for Kidney Failure, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
marwa k abdo, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Quality of Life, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin g shawky, Resident (01281006606, Justen.18313387@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life score (time frame: At baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821788, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.